# The Active Implantable Medical Devices Regulations 1992, Paragraph 3: General requirements


The characteristics and performances referred to in paragraphs 1 and 2 shall not be adversely affected to such a degree that the clinical condition or safety of the patient or of other persons is compromised during the lifetime of the device expected by the manufacturer, where the device is subjected to stresses which may occur during normal conditions of use.

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Source: https://www.legislation.gov.uk/uksi/1992/3146/schedule/2/paragraph/3 (the official version)
Page: https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-2/paragraph-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.